Terumo recalls 6-inch Advanced Perfusion System 1 Roller Pump (catalog 816571) due to potential shaft failure causing noise and pump stoppage during blood circulation procedures.
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
Terumo is recalling a specific blood pump model used in medical procedures because its pump shafts may fail at the locknut location, causing unusual noise and potential pump stoppage. This could lead to interrupted blood circulation during critical medical procedures.
The pump shafts can fail at the locknut connection point, causing unusual noise. If the unsecured shaft end contacts the rotating pulley, prolonged use may lead to pump stoppage due to pulley loosening and drive belt damage, interrupting blood circulation.
Medical professionals using this roller pump for blood circulation procedures are most at risk. Patients undergoing cardiopulmonary bypass or similar treatments may be affected if the pump fails during surgery.
Check for the catalog number 816571 on the pump. The pump was sold with serial numbers starting from 7919 through 8313 and other numbers listed in the recall notice.
Look for unusual noise during operation, which may indicate shaft failure at the locknut connection.
Reach out to Terumo Cardiovascular Systems Corporation for specific guidance on whether your pump needs repair or replacement.
The pump shafts may fail at the locknut connection point, causing unusual noise and potential pump stoppage during blood circulation procedures.
Check for unusual noise during operation. Contact Terumo Cardiovascular Systems Corporation for specific guidance on whether your pump needs repair or replacement.
The recall indicates potential risk of pump stoppage due to shaft failure, so it's recommended to check for unusual noise and contact Terumo for guidance.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1109-2020 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1109-2020 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
